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Association of TARCEVA (erlotinib) with cases of gastrointestinal perforation, Stevens-Johnson syndrome, and corneal perforation - For the Public
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(PDF Version - 51 K)Contact: Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS)
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This is duplicated text of a letter from Hoffmann-La Roche Limited.
Contact the company for a copy of any references, attachments or enclosures.
PUBLIC COMMUNICATION
Health Canada Endorsed Important Safety Information on TARCEVA (erlotinib)
May 8, 2009
Subject: Information on the association of TARCEVA® (erlotinib) with perforation of the bowel/gut, serious skin toxicities and eye disorders
Hoffmann-La Roche Limited, in consultation with Health Canada, has informed Canadian health care professionals of new important safety information regarding the association of TARCEVA® (erlotinib) with perforation of the bowel/gut, serious skin toxicities and eye disorders.
TARCEVA is used to treat patients with non-small cell lung cancer at an advanced stage in which chemotherapy has not helped to stop the disease.
- Rare cases have been reported in which patients have developed perforation of the bowel/gut.
- Very rare cases have been reported in which patients have developed serious skin toxicities and/or eye disorders.
- It is important that you tell your physician of any changes with regards to your skin or eyes as well as any stomach/intestinal pains you might be experiencing while you are on TARCEVA.
It is important to carefully read the Consumer Information (package insert) as this gives details about what information you should tell your physician.
You should consult your physician immediately if you experience any of the following signs or symptoms:
- nausea
- vomiting
- stomach pain
- swollen or enlarged abdomen
- eye pain or vision difficulties
- skin rash, discolouration, blistering, or pain
The TARCEVA Product Monograph is currently being reviewed by Health Canada in conjunction with the manufacturer regarding the above mentioned safety concerns and will be updated accordingly.
Managing marketed health product related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any occurrence of serious and/or unexpected adverse reactions in patients receiving TARCEVA should be reported to Hoffmann-La Roche Limited, or Health Canada at the following addresses:
Drug Safety Department
2455 Meadowpine Boulevard
Mississauga, Ontario, L5N 6L7
or call toll free at: 1-888-762-4388
or Fax at: 905-542-5864
or email to: mississauga.drug_safety@roche.com
Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
Ottawa, Ontario, K1A 0K9
Telephone: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Telephone: 866-234-2345
Fax: 866-678-6789
CanadaVigilance@hc-sc.gc.ca
The Adverse Reaction Reporting Form and the Adverse Reaction Guidelines can be found on the Health Canada Web site or in The Canadian Compendium of Pharmaceuticals and Specialties.
For other inquiries related to this communication, please contact Health Canada at:
Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS)
E-mail: bmors_enquiries@hc-sc.gc.ca
Telephone: 613-941-3171
Fax: 613-941-1365
Sincerely,
original signed by
Lorenzo Biondi,
Vice President, Medical and Regulatory Affairs
Hoffmann-La Roche Limited
